Drugs

FDA Guidance on Moving Protein NDAs to BLAs

FDA has posted a draft guidance (XXINSERT LINKXXX) entitled “Deemed to be a License Provision of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) ” that describes the agency’s approach for transferring protein products that were approved as NDAs to licensed BLAs that adhere to the regulatory scheme of the Public Health Service Act effective 3/23/2020. The agency explains that the BPCI Act changed the statutory authority under which these protein products will be regulated by amending the statutory definition of a “biological product” in the PHS Act to include a “protein (except any chemically synthesized polypeptide).”

The draft guidance notes that the agency will not approve any pending or tentatively approved NDAs for a biological product under the FD&C Act after 3/23/2020. It also provides recommendations to sponsors of proposed biological products intended for NDA that may not receive final approval by the 2020 deadline. “Sponsors with product-specific questions should contact the relevant review division within the Office of New Drugs in FDA’s CDER regarding the development of a biological product intended for submission in a marketing application under the FD&C Act (during the transition period ending on March 23, 2020) or under section 351(a) or 351(k) of the PHS Act, as appropriate,” it says.

Additionally, FDA says that any unexpired exclusivity associated with an approved NDA for a biological product would be erased after the 2020 deadline. However, any unexpired orphan drug exclusivity would continue to apply to the drug for the protected use after the deadline.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome